CS Index Smart Finance — On the evening of January 11, Huadong Medicine (000963.SZ) announced that DR10624, a global first-in-class long-acting triple agonist independently developed by its majority-owned subsidiary, Zhejiang Doer Biologics Co., Ltd., has recently been included in the Breakthrough Therapy Program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug targets the Fibroblast Growth Factor 21 Receptor (FGF21R), Glucagon Receptor (GCGR), and Glucagon-Like Peptide-1 Receptor (GLP-1R), with the proposed indication for Severe Hypertriglyceridemia (sHTG).
According to the announcement, DR10624 is a trispecific agonist targeting FGF21R, GCGR, and GLP-1R. It received clinical trial approvals from China’s CDE and the U.S. FDA in October 2023 and October 2025, respectively, for the treatment of sHTG. The Phase II clinical study results for sHTG were featured as a Late-Breaking Science presentation at the 2025 American Heart Association (AHA) Scientific Sessions. Data revealed that after 12 weeks of treatment, the 12.5 mg dose group achieved a 74.5% reduction in triglycerides. All dosage groups demonstrated potent lipid-lowering effects and significantly reduced liver fat content, while maintaining a favorable safety and tolerability profile.
The announcement further noted that sHTG is a pathological condition characterized by severely elevated triglyceride levels, with a global prevalence of approximately 1% in adults. The condition significantly increases the risk of atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis. Since traditional lipid-lowering therapies offer limited efficacy in reducing triglycerides, there is a critical clinical need for more effective treatments.
Huadong Medicine stated that DR10624, with its innovative triple-target synergistic mechanism, has demonstrated potent lipid-lowering efficacy and comprehensive metabolic regulation advantages. It is expected to provide a brand-new therapeutic option for patients with sHTG in the future.

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